Associate Director, Regulatory Operations

Akebia Therapeutics•Waltham, MA

3h•Hybrid

About The Position

The Associate Director, Regulatory Operations is a hands-on leader responsible for shaping how Akebia plans, produces, submits, and manages regulatory information. The role provides strategic and operational leadership for global regulatory submissions while developing scalable processes, standards, systems, and reporting to help Regulatory Affairs operate effectively. It is based in Waltham, Massachusetts, in a hybrid model; employees are expected to come to the office regularly. The role reports to the Senior Director, Regulatory Affairs. The position leads end-to-end submission planning, publishing, and archiving for global regulatory filings supporting clinical development, product registration, and post-approval maintenance. It also owns regulatory content organization and governance across SharePoint and Veeva RIM, supports system administration and GxP system validation, and helps prepare the company for eCTD 4.0. The successful candidate combines submission expertise with systems thinking, change leadership, project management, and hands-on execution. Akebia describes its work as focused on improving the lives of people affected by kidney disease. The company offers eligible regular employees a corporate bonus program or incentive compensation program, as applicable, equity, and benefits including health care, vision, dental, retirement, and PTO. The targeted base salary is $167,650–$207,098 USD, with actual compensation dependent on qualifications, skills, competencies, and experience.

Requirements

BA/BS degree; an advanced degree is preferred.
At least 7 years of highly relevant pharmaceutical or biotechnology experience in Regulatory Operations.
Knowledge and understanding of the drug development process.
Thorough knowledge of eCTD, validation criteria, data standards, submission standards, and applicable regulatory requirements.
Hands-on experience with regulatory information management or electronic document management systems and health authority question and commitment tracking.
Experience with Veeva RIM authoring and publishing.
Experience designing SharePoint information architecture and document governance for regulated content.
Experience with document formatting and authoring templates, and training colleagues on business processes, RIM or EDMS practices, and submission standards.
Strong project management skills, including the ability to manage strategic deadlines, changing requirements, multiple priorities, and operational risks.
Clear, collaborative written and oral communication skills and the judgment to analyze complex issues, build productive stakeholder relationships, and recommend practical solutions.
High attention to detail; strong organization, flexibility, and accountability.
Ability to identify potential issues and mitigate risks, adapt quickly to changing requirements and priorities, and work to strategic deadlines.
Strong interpersonal skills and drive for excellence.
Commitment to Akebia's core values, culture, vision, and mission.
Ability to work in a hybrid model in Waltham, Massachusetts, and come to the office regularly.

Nice To Haves

Advanced degree.
Experience creating operational dashboards or portfolio reporting with Smartsheet, Microsoft 365, or comparable tools.
Experience managing consultants, vendors, contracts, budgets, or invoices.

Responsibilities

Provide strategic and operational leadership for Regulatory Operations, helping set functional direction, plan and build capabilities, and deliver timely, high-quality submissions.
Shape and continuously improve Regulatory Operations processes, governance, roles, handoffs, and quality controls.
Develop and maintain standard operating procedures, training materials, job aids, and other resources for consistent execution.
Lead end-to-end planning, publishing, and archival of global regulatory filings supporting clinical development, product registration, and post-approval product maintenance.
Manage internal and external submission activities, schedules, dependencies, quality checks, and delivery risks, including work with business partners and third-party vendors.
Administer the RIM system and provide direct support to functional disciplines, content owners, and program teams responsible for submission content.
Organize, archive, and track global health authority correspondence, submissions, questions, and commitments, with a primary focus on the United States.
Partner with Regulatory Leads to develop submission plans and timelines, maintain the submission calendar, and coordinate content across functional disciplines and program teams.
Help lead company readiness for eCTD 4.0 by monitoring requirements, assessing gaps, and developing a transition roadmap for systems, metadata, processes, validation, vendor capabilities, training, and change management.
Provide project management support and generate timelines for regulatory interactions and submissions.
Provide hands-on document formatting, report-level publishing, compilation, and troubleshooting support as needed.
Own the organization and maintenance of Regulatory content in SharePoint and Veeva RIM, including information architecture, taxonomy, metadata, naming and versioning conventions, access controls, retention, and archival standards.
Establish an intuitive, reliable source of truth for submissions, health authority correspondence, questions, commitments, and other critical records, enabling inspection-ready retrieval and appropriate access.
Lead change management and support validation activities for GxP computerized systems, encouraging consistent and effective use of Regulatory systems and tools.
Build dashboards, calendars, metrics, and portfolio views to make milestones, commitments, workload, dependencies, risks, and team contributions visible to stakeholders and leadership.
Identify and implement digital, automation, and workflow improvements that reduce manual effort, strengthen quality, and improve content and submission processes.
Translate operational data into clear updates and recommendations for prioritization, resource planning, and timely decisions.
Develop collaborative relationships with internal stakeholders, business partners, consultants, and vendors; manage contracts, budgets, and invoices as needed.
Perform other Regulatory Operations duties as assigned.